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Health Data Lab


Added by:   National contact point
Added on:   02 Oct 2025
Updated by:   OECD analyst
Updated on:   25 Dec 2025

The Health Data Lab (HDL) at the Federal Institute for Drugs and Medical Devices makes pseudonymised claims data from people insured in the statutory health system available for research purposes and other legally defined public interest purposes, including AI development, the HDL makes an important contribution towards better and safer healthcare. With the Act on Health Data Use the Social Security Code – Book V (SGB V) has been amended to explicitly enable the development of AI systems.

Name in original language

HDL – Forschungsdatenzentrum (FDZ) Gesundheit

Initiative overview

The Health Data Lab (HDL), hosted at Germany’s Federal Institute for Drugs and Medical Devices (BfArM), is structured to provide pseudonymized claims data from citizens insured under the statutory health system for research and public interest uses—explicitly including development of AI applications. It emerged from the reorganisation of the former DIMDI unit and is grounded in legal reforms such as the Data Transparency Regulation (DaTraV) and the Health Data Use Act.

Name of responsible organisation (in English)

Federal Institute for Drugs and Medical Devices

Mechanisms to involve stakeholders in strategy design, implementation or monitoring

Don't know

About the policy initiative


Organisation:

  • Federal Institute for Drugs and Medical Devices

Category:

  • AI policy initiatives, programmes and projects

Initiative type:

  • Initiative to promote data access and sharing

Status:

  • Active

Start Year:

  • 2013

Binding:

  • Non-binding

Other relevant urls: